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FDA 510(k)

BIAFINE Topical Cream

K-Number: K190342 · 2019-10-18

ApplicantBausch Health Americas Incorporated
Decision Date2019-10-18
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BIAFINE Topical Cream is the device name listed in this FDA 510(k) record. The listed applicant is Bausch Health Americas Incorporated. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K190342. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIAFINE Topical Cream?

BIAFINE Topical Cream is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Bausch Health Americas Incorporated. The 510(k) number is K190342.

When did BIAFINE Topical Cream receive FDA 510(k) clearance?

BIAFINE Topical Cream received FDA 510(k) clearance on 2019-10-18, under 510(k) number K190342.

Who is the listed applicant for BIAFINE Topical Cream?

The FDA 510(k) record lists Bausch Health Americas Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIAFINE Topical Cream?

The FDA product code for BIAFINE Topical Cream is FRO. This falls under the Anesthesiology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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